A Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02615093
• Other study ID #: Valeant 302
• Status: Recruiting
• Phase: Phase 3
• First received: November 17, 2015
• Last updated: November 25, 2015
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Sadick Research Group
• Contact: Krista Bohnert
• Phone: 2127727242
• Email: kbohnert[@]sadickdermatology.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a double-blind study to evaluate the safety and efficacy of topical IDP-118 Lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Description:

Patients will be randomized in a 2:1 ratio to receive IDP-118 Lotion and IDP-118 Vehicle Lotion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at lease 3%, but no more than 12%

• is willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study

• is in overall good general health

• if female, is not pregnant, planning to become pregnant or breastfeeding.

Exclusion Criteria:

• has received treatment with a biologic within the past 3 months

• is currently using lithium or Plaquenil

• has a history of drug or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• IDP-118 Lotion
The study drug will be applied topically to the affected areas (as determined by the investigator at baseline) once daily for 8 weeks.
• Vehicle Lotion
Vehicle lotion will be applied topically to the affected areas (as determined by the investigator at baseline) once daily for 8 weeks.

Locations

Country	Name	City	State
United States	Sadick Research Group	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sadick Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessments: local skin reactions, adverse events, Safety Laboratory Tests, abbreviated physical exam	The efficacy endpoints are intended to compare once daily application of IDP-118 Lotion and vehicle. Specifically, the efficacy endpoints include- The percent of subjects with treatment success, defined as at least a 2 grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, 8 and Week 12 (4-week follow-up), as summarized using descriptive statistics. The percent of subjects with at least a 2-grade improvement from Baseline in the score for each of the signs of psoriasis (erythema, plaque elevation, and scaling) at Weeks 2, 4, 6, 8 and Week 12 (4 week FU), as summarized using descriptive statistics for the target lesion treated with study drug.	8-weeks	No